Systems and methods for identifying the nature of defects in medical scopes, and determining servicing and/or future use of the scopes

ABSTRACT

Methods and systems identify defects in a medical device and tailor a protocol, namely, further recommended action, for the device based on a combination of the nature of the defects and procedural data including patient data and/or medical instrument record data. Computer-implemented instructions are used to determine the presence and nature of the defects. Artificial intelligence and/or algorithms may be used to implement the computer-implemented instructions, and process image data from a digital camera system. Upon identification of a defect present, the detection system may notify users of the presence of the defect, as well as provide further recommended action to be taken regarding the medical device, reducing potential instrument failure, patient injury or death. The methods and systems may be integrated into existing disinfection and sterilization systems and techniques currently used in medical facilities, such as hospitals and surgery centers.

This application claims priority to U.S. application Ser. No.16/912,337, filed on Jun. 25, 2020, entitled “Systems and Methods forDetecting Defects in Medical Devices,” which in turn claims priority toU.S. Provisional Application Ser. No. 62/866,535, filed Jun. 25, 2019,the contents of which are hereby incorporated by reference in theirentirety.

BACKGROUND 1. Field

The present technology relates to medical devices and to thereprocessing of medical devices post-procedure. In particular, thepresent technology relates to the inspecting of medical scopes in areprocessing procedure to determine protocols for servicing and futureuse of the medical scopes.

2. Description of the Related Art

Medical devices, such as colonoscopes, laparoscopes, and arthroscopes,are used in the performance of over 18 million medical procedures in theUnited States every year. After each medical procedure the associatedmedical device is reprocessed for use in another upcoming procedure. Areprocessing procedure, for example, may include a cleaning andsterilization of the medical device, followed by a visual inspection ofthe various working channels of the medical device to determine whethera defect still exists. The defect may be a biological defect, forexample, the defect being bio-burden within a portion of a workingchannel of the medical device. Examples of bio-burden may include, butare not limited to, biological fluids, such as blood, biologicaltissues, and/or various forms of bacteria. Alternatively, the defect maybe mechanical in nature. For example, the medical device itself may beexcessively worn or damaged during use. The mechanical defect may be abreak or crack, or other mechanical failure in the physical structure ofthe medical device, which may lead to the undesirable transmission ofbio-burden or other non-biological material between the working channelof the medical device and a patient's body cavity. Last, the defect maybe a portion of non-biological material originating from the medicaldevice itself, or a working device positioned within the correspondingworking channel during the performance of a medical procedure.

If one or more such defects are present but are not discovered orobserved during the reprocessing procedure the one or more defects maycontaminate a patient in a future medical procedure. These undiscovereddefects may be a primary source of healthcare-acquired infections, thereprocessed medical devices being a source of hospital borne infections,leading to undesirable patient injury or even death. Some studies havefound that up to 70% of reprocessed medical devices are contaminatedwith various forms of bio-burden.

In an attempt to limit the biological and mechanical defects found inmedical devices after the performance of a medical procedure, and as maybe required for compliance with various standards organizations,healthcare facilities are increasingly purchasing inspection systems toprovide an inspection technician visual access to various structures ofa medical device, including the internal working channels. Suchinspection technicians, however, may not be highly educated or motivatedand may be under tremendous pressure to complete medical deviceinspections in a timely manner so the associated medical devices may beutilized in upcoming medical procedures. Present visual inspectiontechniques performed by inspection technicians, however, are highlydependent on human interaction and judgement, and are subject to humanerror, which may lead to errors in defect detection and, ultimately,patient injury or death due to the presence of the defect, whetherbiological or mechanical, and subsequent contamination of the patient.

Additionally, direct visual inspection systems allow users earlydetection of mechanical defects that may lead to medical instrumentfailure. Medical device failure during medical procedures is notuncommon and may cause procedural interruptions lasting several minutesor more. The ability to predict failure through early detection ofmechanical defects, therefore, has value to medical providers andpatients.

Accordingly, there is a need for a detection system adapted to determinethe presence of defects in medical devices, and to identify the natureof such defects. A detection system to provide for a more reliablereprocessing procedure to minimize human interaction, minimizevariations due to human judgement, and increase user notifications isdesirable, such notifications including whether a defect is present andwhether the defect is a biological defect or a mechanical defect. Adetermination by the detection system whether the medical device shouldbe reprocessed once again or removed from service is also desired.Further, a detection system that can integrate into existingdisinfection and sterilization systems currently utilized by medicalfacilities in reprocessing procedures is also desirable.

SUMMARY

Consistent with the present disclosure, a detection system is providedto perform methods for detecting defects in medical devices, during areprocessing procedure, for example. The detection system may utilizecomputer-implemented instructions to determine the presence and natureof the defects, whether liquid, biological or mechanical, for example.The computer-implemented instructions may be adapted to includeartificial intelligence and/or machine learning algorithms, and processimage data from currently available digital inspection camera systems orproprietary camera systems, as desired. Upon identification of a defectpresent in a medical device, the detection system may notify users ofthe presence of the defect, as well as provide further recommendedaction to be taken regarding the medical device, if desirable, reducingpotential instrument failure, patient injury or death. The discloseddetection system may be integrated into existing disinfection andsterilization systems currently used in medical facilities, such ashospitals and surgery centers, for example. Related methods are alsoprovided according to an aspect of the present technology.

For example, according to one aspect of the present technology, a methodfor detection of defects of a medical device includes obtainingprocedural data related to the medical device, positioning a detectionscope within the medical device, acquiring one or more images at acurrent location of the detection scope, advancing the detection scopewithin the medical device, identifying one or more defects within themedical device, and updated the procedural data related to the medicaldevice. In certain embodiments, the procedural data includes one or moreof a medical instrument record, a service record, and a meta datarecord. Positioning the detection scope may include positioning thedetection scope within a working channel of a medical device. Adetermination whether an end of the working channel is reached by thedistal tip of the detection scope may be determined.

In certain embodiments, steps of acquiring the plurality of images,advancing the detection scope, identifying defects, and determiningwhether the end of the working channel of the medical device has beenreached may be repeated one or more times. Once the end of the workingchannel is reached by the distal tip of the detecting scope proceduraldata may be updated.

In some embodiments, identifying one or more defects entails determininga location for each of the one or more defects. Determining the locationfor each of the one or more defects may include performing an opticalflow analysis. Determining the location for each of the one or moredefects may further include measuring an acceleration of the distal tipof the detection scope. In some embodiments, determining the locationfor each of the one or more defects includes measuring a ratio betweenthe rotational movement of the motor and the linear movement of thedetection scope.

According to another aspect of the present technology, a device fordetection of a defect of a medical device includes an imaging deviceconfigured to acquire image data, a processor coupled to the imagingdevice, the processor configured to analyze image data received from theimaging device, and a data source coupled to the processor, the datasource adapted to store image data acquired by the imaging device, amongother things.

In some embodiments, the device further comprises an input devicecoupled to the imaging device and the processor, the input devicetransmitting image data between the imaging device and the processor.The input device may be adapted to control the characteristics of theimage device. The data source may include a meta data record, a medicalinstrument record, and a service data record.

In some embodiments, the input device may be configured to couple to theimaging device wirelessly, and the input device may be configured tocouple to the processor wirelessly. The input device may also beconfigured to process image data prior to passing the image data on tothe processor.

According to another aspect of the present technology, there is provideda method of servicing a medical device, which includes imaging a workingchannel of the medical device with a detection scope to produce imagedata of the working channel, transmitting the image data to a processor,and identifying defects of the medical device present along the workingchannel from a select group of different types of defects by analyzingthe image data using the processor. Defect data representative of thetypes of defects present along the working channel is produced as aresult of the analysis. Procedural data is also obtained. The proceduraldata includes meta data of at least one patient who has undergone or isscheduled to undergo the medical procedure and/or device record dataindicative of a historical record of use of the medical device. Themedical device may then be scheduled for servicing, removal fromservice, or for use in a next procedure without undergoing servicing,based on the procedural data and the defect data. In this respect, thedefect data may be used to update the procedural data and the schedulingof the medical device may be determined by the processor throughanalysis of the updated procedural data.

According to still another aspect of the present technology, there isprovided a method of servicing a medical device, which includes imaginga working channel of the medical device with a detection scope toproduce image data of the working channel, and using artificialintelligence (AI) to identify defects of the medical device presentalong the working channel from a select group of different types ofdefects through analysis of the image data. Defect data representativeof the type of any defect identified along the working channel isgenerated. Also, procedural data is obtained from at least one memory.The procedural data includes meta data of at least one patient who hasundergone or is scheduled to undergo the medical procedure and/or devicerecord data indicative of a historical record of use of the medicaldevice. The medical device may then be scheduled for servicing, removalfrom service, or for use in a next procedure without undergoingservicing based on the procedural data and the defect data. In thisrespect, the defect data may be used to update the procedural data andthe scheduling of the medical device may be determined by AI.

According to still another aspect of the present technology, there isprovided a medical device defect detection system, which includes animaging device, a processor operatively connected to the imaging device,and at least one memory, the imaging device comprising a detectionscope, the processor being operatively connected to the imaging deviceto receive image data from the detection scope, and the at processorbeing configured to analyze the image data, identify defects of themedical device from a select group of different types of defects byanalyzing the image data, and generate defect data representative of thetypes of defects. The detection scope is insertable into a workingchannel of a medical device and includes an image sensor that capturesimages adjacent a distal end of the detection scope, including those ofany of select defects present along a working channel of the medicaldevice. The at least one memory stores procedural data including metadata of at least one patient who has undergone or is scheduled toundergo a medical procedure of a type performed by the medical device,and device record data indicative of a historical record of use of themedical device. The processor is operatively connected to the at leastone memory and is configured to receive the procedural data from the atleast one memory as well as update the procedural data using the defectdata. The updated procedural data is analyzed by the at least oneprocessor to recommend a further course of action for the medicaldevice, namely, to schedule the medical device. The schedule may be aservicing of the medical device, e.g., a reprocessing procedure, removalfrom service, or use in a next procedure without undergoing servicing.

Thus, the present technology can offer a better determination regardingthe servicing and future of a medical device as compared to humandecision-making based on visual inspection of images of the medicaldevice.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, features and advantages of the presenttechnology will be better understood from the detailed description ofthe present technology that follows with reference to the accompanyingdrawings. The drawings are intended to be illustrative, not limiting.Therefore, although certain embodiments or examples and aspects of thepresent technology are described in detail, it should be understood thatsuch description is not intended to limit the scope of the inventiveconcept realized by the disclosed embodiments of the present technology.In the drawings:

FIG. 1 is a perspective view of part of an exemplary endoscopic deviceutilized in medical procedures including one or more working channels.

FIGS. 2A-2N are images of various examples of defects that may bepresent in a medical device after a reprocessing procedure.

FIG. 3 is a schematic diagram of an example of a detection systemaccording to the present technology.

FIG. 4 is a perspective view of a detection scope constituting theimaging device of the detection system of FIG. 3 .

FIG. 5 is a flowchart illustrating an example of a method of setting aprotocol for future use of a medical scope according to the presenttechnology.

FIG. 6 is a flowchart of an example of a routine in the method of FIG. 5.

FIGS. 7A-7D are images of medical instruments during defect analysis anddetection according to the present technology.

FIG. 8 is a flowchart illustrating another routine of the method of FIG.5 .

DETAILED DESCRIPTION

Systems and methods for detecting defects in medical devices aredisclosed, such defects being liquid, biological (both liquid andnon-liquid) or mechanical, for example. The methods described herein arecomputer-implemented methods comprising a processor and processorexecutable instructions stored in a memory accessible by the processor,whether local or remote. Here, the term processor will be understood asencompassing controllers, and the term memory will be understood asbeing used synonymously with the term data source. Similarly, the termmedical device will be understood as being used synonymously with theterm medical instrument.

The following description is set forth to provide an understanding ofthe various embodiments of the present technology. However, as should beapparent, one skilled in the art will recognize that the presenttechnology may be embodied by numerous other methods, assemblies,systems and devices.

The embodiments of the present technology may include certain aspectseach of which may be present in, or performed through the use of, one ormore medical devices, assemblies, or systems thereof. Furthermore, theillustrated embodiments and examples disclosed herein may include moreor less structures than depicted and are not intended to be limited tothe specific depicted structures. While various portions of the presenttechnology are described relative to specific structures, methods, orprocesses with respect to a medical device, assembly, or system usingspecific labels these labels are not meant to be limiting.

A detection scope described herein, as part of a detection system forexample, may be part of an existing inspection system utilized at amedical facility. Alternatively, the detection scope or fiber scope maybe a proprietary scope. Such detection scopes may be made from anysuitable biocompatible material, including but not limited to metals,metal alloys (e.g., stainless steel) and polymers (e.g., polycarbonate),and may be formed using any appropriate process, such as extrusion ormilling, screw-machining or molding (e.g., injection molding).Furthermore, detection scope assemblies described or contemplated hereinmay have any suitable dimensions, such dimensions allowing the detectionscope to be positioned within and pass through the various workingchannels of a medical device as part of or in preparation forreprocessing, for example.

Reference will now be made to the accompanying drawings in which thepresent technology is shown.

Turning to FIG. 1 , an exemplary medical endoscope or scope 100 utilizedin a medical procedure may include an elongate shaft 102, having adiameter Di, terminating in a distal end 104. The medical endoscope 100may include one or more working channels 120 through which fluids orother medical devices may flow or be positioned, respectively, each ofthe working channels 120 having a respective diameter. The medicalendoscope 100, for example, could be an endoscope utilized in a medicalprocedure, such as a colonoscope, a laparoscope, a cannula assembly, anarthroscope, an accessory such as arthroscopic shaver component, or thelike. Depending upon the type of scope and procedure, exemplary medicaldevices provided to be transmitted through the one or more workingchannels 120 include ablating devices, irrigation devices, and/or tissuesampling devices, to name a few. Such medical devices may contaminatethe corresponding one or more working channels 120 with bio-burden, orbiological defects, as described above. Additionally, excessive use ofthe medical devices, or the endoscopic system itself, may result inmechanical defects or non-biological debris being positioned within aportion of the one or more working channels 120 of the endoscope 100.

Turning to FIGS. 2A-2N, examples of various defects, indicated asdefects 200D_(x), will be described in greater detail. Once a medicaldevice is utilized in a medical procedure, such as the endoscope 100,the medical device may then be reprocessed in preparation for use in afuture medical procedure. Any of various exemplary defects 200D_(x) maybe discovered after such a reprocessing procedure. Biological defectsmay lead to patient infection and/or injury. Mechanical defects mayallow microbiological accumulations to take place in areas impossible toclean or decontaminate or may allow biological or non-biologicalmaterials to pass through a wall of a surgical instrument, suchmaterials potentially contaminating a patient's body or other portionsof the surgical instrument being utilized.

For illustration purposes only, and with specific reference to FIG. 2A,a defect 200D₁ is depicted being located within a lumen 230A of asurgical instrument 200. The defect 200D₁ is a metal shard or patch ofcorrosion present in the lumen 230A. Turning to FIG. 2B, a defect 200D₂is depicted in a lumen 230B of a surgical instrument 202, the defect200D₂ being diffuse rust and corrosion. FIG. 2C depicts mechanicaldefect 200D₃ depicted along a portion of a lumen 220C as part of anarthroscopic shaver 204. Such mechanical defect 200D₃ may include apatch of rust and corrosion produced, for example, through translationof medical devices through the lumen 200C, which may, in turn, result inmetal or plastic filings invading the lumen 220C. Mechanical defect200D₃ may also include separation of various elements of the shaver 204,such as metal separation, which may allow for leakage of biologicalmaterial from one portion of the shaver 204 to another, or into a bodycavity of a patient. Disruption of the normal materials or interruptionof the surface characteristics associated with various lumens ofsurgical instruments may provide a lodging point or substrate for anundesirable formation of biofilms and/or microbiological colonies.

Turning to FIG. 2D, foreign material or defect 200D₄ is depicted near alumen 230D of surgical instrument 206. FIG. 2E depicts defect 200D₅,which may include staining and a mechanical defect in the wall of alumen 230E of a surgical instrument 208, while FIG. 2F depicts defect200D₆ in the form of material dislodged from a wall of a lumen 230F of aflexible surgical instrument 210. Now turning to FIG. 2G, mechanicaldefect 200D₇ may be severe degradation of wall structures associatedwith a lumen 230G of a flexible endoscope. FIG. 2H depicts mechanicaldefect 200D₈ in the form of a crushed lumen 230H of a flexible endoscope214, and FIG. 2I depicts another structural defect 200D₉ in a lumen 2301of a surgical instrument 216.

Turning to FIG. 2J, defect 200D₁₀ is in the form of fluid that may haveremained within a lumen 230J of a flexible endoscope 218 after asurgical procedure or a reprocessing procedure. FIG. 2K, as with FIG.2J, also depicts fluid as defects 200D₁₁ in a lumen 230K of a flexiblesurgical instrument 220. With reference to FIG. 2L, a defect 200D₁₂ islocated within a working channel or lumen 230L of a medical instrument222.

The defect 200D₁₂ may be a biological defect such as a hair fiber or maybe a non-biological defect such as a clothing fiber, for example. FIG.2M also depicts fiber defect 200D₁₃ located with a lumen 230M of amedical instrument 224. FIG. 2N depicts foreign material as defect200D₁₄, within a lumen 230N of a surgical instrument 226. All of thedefects 200D_(x) have been discovered after a reprocessing procedure hasbeen performed, and each defect 200D₁-200D₁₄ may result in undesirablepatient contamination, patient injury or death during future medicalprocedures.

Turning to FIG. 3 , a detection system 300, in accordance with thepresent technology, may include an imaging device 310, an input device320, a processor 330, and one or more data sources. Such data sourcesmay include a meta data record (MDR) 340, a Medical Instrument Record(MIR) 350, and a service data record (SDR) 360. The one or more datasources may include sufficient data to allow for a proper analysis and,ultimately, a better determination regarding the inspection and futureuse of a corresponding medical device or instrument; an increase in theamount of acquired data may directly lead to the better determination.

The detection system 300 may include computer-executable code thatallows for obtaining information from and storing information to the oneor more of the data sources 340, 350, 360. While depicted as being threeseparate data sources, the data sources 340, 350, 360 may be part of anynumber of one or more data sources. Additionally, while the elements ofthe detection system 300 are depicted being directly connected to theprocessor 330, such connections may be through wired or wirelesscommunication links, and the locations of each element of the detectionsystem 300 may be local or remote with respect to remaining ones of theelements of detection system 300. For example, the imaging device 310may be configured to acquire imaging in a room where the reprocessingprocedure is taking place, the room being part of a medical facility,and transmit the imaging to a remotely located processor 320, which thencommunicates associated data, derived from an analysis of the imaging,with the various data sources 340, 350, 360, each being located in aseparate location from the processor 330.

The imaging device 310 may have the ability to capture images at aspecified rate and transfer the corresponding image data via an inputdevice 320 to the processor 330 for further processing. The image device310 may include processing of its own such that the image data ispreprocessed prior to being provided to the processor 330.Alternatively, the image device 310 may simply provide raw image data tothe processor 330, which may provide further processing of the receivedimages. Turning also to FIG. 4 , an exemplary imaging device 400 may beone of a plurality of different inspection or fiber scopes, as part ofan inspection scope system currently available that can provide imagingdata, as discussed below, which then can be digitized for analysis bythe detection system 300, for example. The imaging device 400 may be ascope having an elongate shaft 402, which terminates at a distal end404. The distal end 404 may include a light source 410 and an imagesensor 412 to illuminate and capture images while the imaging device 400is positioned within a working channel of a medical device during areprocessing procedure, for example. The elongate shaft 402 of theimaging device 400 may be configured to be suitable for being positionedwithin working channels of medical devices, such as working channels 120of scope 100. The elongate shaft 402, for example, may have a diameterD₂ that is smaller than a diameter of any of the one or more workingchannels 120 of scope 100. Additionally, the elongate shaft 402 may havea suitable length to be extended through a working channel of a medicaldevice, such as the working channel 120 of endoscope 100. One or boththe light source 410 and image sensor 412 may be located at the distalend 404 of the imaging device 400. Alternatively, either of the lightsource 410 or the image sensor 412 may be positioned proximal to thedistal end 404, or at a proximal end of the elongate shaft 402, in ahandle portion, for example. If the light source 410 is positionedproximal to the distal end 404 of the scope 400, light generated by thelight source 410 may be transmitted to the distal end 404 through anysuitable means, e.g., through one or more optical fibers (not shown),positioned within the elongate shaft 402. The one or more optical fibersmay terminate at the distal end 404 of the elongate shaft 402 via a lensportion (not shown) that may focus the light in a desired manner.

Additionally, light may be transmitted from the distal end 404 of theelongate shaft 402 to a more proximally positioned image sensor 412 viaone or more optical fibers, the one or more optical fibers terminatingat the distal end 404 via a lens portion (not shown) configured tocollect light provided by the light source 410. The light generated bythe light source 410 and obtained by the image sensor 412 may be in thevisible range, or may have a wavelength outside the visible range, butis better suited to illuminate and define the inner structures of amedical device being reprocessed. While the light source 410 and imagesensor 412 are depicted as being separate elements, they may be formedas a single unit allowing for a smaller diameter D₂ allowing the imagingdevice 400 to be utilized in medical devices having working channelswith correspondingly smaller diameters.

Alternatively, the methods of the present technology may be executedusing existing scopes utilized by medical facilities in reprocessingprocedures, rather than the scope 400. Such existing scopes withadequate image acquisition may be adapted to provide the acquiredimaging to the processor 330 of the detection system 300, utilization ofthe existing scopes reducing associated costs of the medical facility,while increasing the efficiency and accuracy of a reprocessingprocedure. If required, the existing scopes of associated inspectionsystems may be further adapted to provide for image acquisition suitablefor use with the detection system 300. For example, an alternative lightsource may be able to be utilized to increase available light, or a lensportion may be fitted upon a distal end of the existing scope toincrease the scope's ability to transmit and receive light.

Turning back to FIG. 3 , the imaging device 310 may communicate with theinput device 320 over a bidirectional link 312. The bidirectional link312 may allow for transmission of image data from the imaging device tothe input device 320 and, ultimately, to the processor 330 for analysis.The bidirectional link 312 may also provide commands to the image devicefrom the input device 320, or the processor 330, such as when toinitiate imaging capture, or the rate of movement of the scope through aworking channel of a medical device, for example. While depicted asproviding transmissions from the imaging device 310 to the input device320 over link 312, some or all of such transmissions may be communicateddirectly to the processor over another bidirectional communication link(not shown).

The input device 320 may be any suitable device having the ability toobtain or direct imaging data from the imaging device 310 to theprocessor 330. The input device 320 may be configured to executecomputer-executable code independent of the processor 330. For example,the input device 320 may be a tablet, such as an iPad®, or othercomputing device, such as a desktop or laptop computer system, allowingan inspection technician to log into the detection system 300 andprovide data and command communication therebetween. Once logged intothe detection system 300 the technician may initiate an inspectionprocess by instructing the imaging device 310 to start acquiring imagingdata. The input device 320 may communicate with the processor 330 over abidirectional communication link 322. The input device 320, once aninspection technician has logged into the detection system 300, may beconfigured to receive user interface data from the processor 330. Suchuser interface data may then be utilized to provide a desired userinterface on the input device 320 tailored for that specific inspectiontechnician based upon their login criteria and the specific type ofinspection they will be performing. Additionally, imaging data receivedby the input device 320 from the imaging device 310 may be transmittedto the processor 330 on the communication link 322. As will become morereadily apparent in light of the discussion below, the communicationlink 322 may be utilized to provide additional data, data resulting fromanalysis of the processor 330, for example, to a user of input device320, the user being a medical facility risk manager or quality assurancemanager, for example, who wishes to see part or all of the dataassociated with a medical device or instrument. In this case the userinterface provided to this user may be different than the user interfaceprovided to the inspection technician for data gathering. Accordingly,the user interface may be different depending on the specific role ofthe end user at the input device 320. All or part of the functionalityof the processor 330 may be provided by the input device 320 itself, asdesired by the end user.

The processor 330 may interface with one or more of the data sources340, 350, 360 prior, during, or after a medical procedure to correlateassociated procedure data. Meta data, for example, may be obtained fromthe MDR data source 340. Such meta data may include, for example,patient data approved by the patient to be part of the data source 340,deidentified patient data, and/or medical data derived from medicalstudies related to a medical procedure to be performed on a patient, forexample. The detection system 300 may obtain deidentified patient datathrough analysis of patient documents, redacting certain data specificto the patient, including imaging data that may include facial featuresof the patient. The meta data may include, for example, anomalies inpatient biology that would render a specific medical device improper fora given medical procedure due to an increased inflexibility of themedical device over its lifetime, or the existence of excessive wearthat would make mechanical failure of the medical device more imminent.For illustration purposes, the detection system 300 may be utilized toanalyze meta data and corresponding procedural data, noting acommonality such as a high number of patient readmissions for infection,for example. A further analysis of the data may then determine themedical instrument or instruments utilized for the procedures. Thedetection system 300 may remove a single medical instrument from furtherpatient use, the medical instrument being determined to likely be thesource for infection and, accordingly, unsuitable for performing futuremedical procedures. Furthermore, an analysis by the detection system 300may determine that a specific type of medical instrument results in anincrease in patient infection due to design constraints, for example,prompting a removal of this specific type of medical instrument fromfuture medical procedures at a medical facility.

The detection system 300 may include computer-executable code thatallows for the tracking of the data of the medical devices utilized incorresponding medical procedures, with associated data being stored in amedical instrument record as part of the MIR data source 350. Medicalinstrument record data may allow technicians, as well as risk managersor quality assurance managers of medical facilities to better monitorthe service status of a medical device or instrument from its initialpurchase and introduction to the medical facility until its removal fromservice, providing a complete historical record of all servicing of themedical device. In this way, the detection system 300 may be able tobetter determine when certain types of mechanical failures of themedical device are imminent, or when the medical device should beremoved from service. This may result in fewer intraprocedural stoppagesor a reduction of time a patient is under general anesthesia, which maylead to increased patient safety and reduced procedural costs. Forexample, when a medical device is purchased, initial data regarding thedevice may be obtained through manual entry by a technician or automaticentry acquired through the use of the detection system 300, resulting inthe initial creation of a service record defining a baseline for themedical device from which to compare future medical device data. Thedata may be associated with the medical device through the use ofsymbolic identifiers, such as bar codes or device identifierspermanently etched into a portion of the medical device. Suchidentifiers may be in compliance with the Unique Device Identifier (UDI)requirements mandated by the U.S. Food and Drug Administration and theEuropean Union. The medical instrument record may provide a historicalrecord of the use of the associated medical device and may providetechnicians or users a more accurate forecast when the medical deviceshould be removed from service, due to excessive wear or mechanicaldefects, for example.

The detection system 300 may include computer-executable code thatallows for the tracking of certain service data, stored as part of theSDR data source 360, related to medical procedures performed at amedical facility, or among a group of medical facilities. Such servicedata may include the procedure performed, the new or reprocessed medicaldevices being utilized during the medical procedure, the location of themedical procedure, the surgeon performing the medical procedure, and themedical procedure support staff. By corelating service data with themedical instrument record data, as maintained and updated by thedetection system 300, a more appropriate medical device may be madeavailable for a given medical procedure. For example, the detectionsystem 300 may schedule the use of a particular medical device for agiven medical procedure performed by a particular surgeon, based uponthe surgeon's habits and operating style. In this way, the lifespan of aparticular medical device may be prolonged, reducing associated productcosts of the medical facility.

One or more elements of the detection system 300 may be locatedremotely, in a data cloud 370, for example. The processor 330 and thedata sources 340, 350, 360 may be remotely located with respect to theinput device 320 and the imaging device 310. Additionally, the processor330 and the data sources 340, 350, 360 may be located in the same datacloud 370, such as a server farm located at one physical location, ormay be part of one or more data clouds, each located at a differentphysical location, but together defining data cloud 370. Thecomputer-executed code of the processor 330 may be an applicationconfigured to run in the data cloud 370 and exchange data and commandsover the bidirectional communication link 322.

Turning to FIG. 5 , a method 500 in accordance with the presenttechnology for reprocessing a medical device may include an initial step510 of obtaining procedural data. Turning momentarily to FIG. 6 , amethod 600 provides a more detailed depiction of step 510 of method 500.More specifically, the step 510 may include one or more of obtaining MIRdata in a step 510A, obtaining service data in a step 510B, andobtaining meta data in a step 510C. Turning back to FIG. 5 , thedetection scope, such as scope 400 or an existing inspection scope ownedby the medical facility, may then be initially positioned within aworking channel of the medical device being reprocessed in a step 512.For example, a digital inspection camera may be adapted to be utilizedby the detection system 300 as imaging device 310 to obtain images fromwhich the status of the medical device may be determined, the digitalinspection camera being positioned within the working channel of themedical device in the step 512.

One or more images may then be acquired by the imaging device, such asdevice 310, and transmitted to the processor 330, via input device 320or directly to the processor 330, in a step 514. Multiple images may betaken at a specific location, the detection system 300 being adapted toselect a desirable image from the multiple images. Once a desirableimage is acquired, the detection scope may then be advanced in a step516. The advancement of the detection scope may be performed manually ormay be provided automatically through the use of a linear actuator (notshown), the control of such advancement of the linear actuator beingprovided by the input device 320 or the processor 330, or a combinationof both. For example, the linear actuator may be utilized to provide fora specified movement over time, e.g., movement at a known rate, whichmay aide in the image analysis and, ultimately, the determination ofbiological or mechanical defects that may be present in the workingchannel of the medical device. Biological or mechanical defects may beidentified in a step 518. The processor 330 may includecomputer-implemented code executed by the detection system 300 thatanalyzes the acquired images in the step 514, utilizing certainalgorithms that may be machine learning or adapted from artificialintelligence.

A determination as to whether the end of the working channel of themedical device is reached may be performed in a step 520. If the end ofthe working channel is not reached, steps 514, 516, 518, respectively,may be repeated. Thus, additional images may be acquired, the detectionscope is further advanced through the working channel of the medicaldevice, and defects present may be identified until the end of theworking channel is reached at decision step 520.

Once the end of the working channel is reached, procedure data may thenbe updated in a step 522. Turning briefly to FIG. 8 , the step ofupdating procedure data may include one or more of updating MIR data ina step 522A, updating service data in a step 522B, and updating metadata in a step 522C. For example, updated MIR data may include thepresence of defects, biological, non-biological, or mechanical, and/orthe extent of wear present in one or more working channels of thereprocessed medical device. As described above, such data may beanalyzed to provide for better medical device selection for a givenpatient, surgeon, and medical device, whether the medical device is atits end of life, or whether the medical device should be reprocessed dueto the presence of defects.

Turning to FIGS. 7A-7D, exemplary defects may be determined by thedetection system 300. For illustration purposes, artificial intelligence(AI) may be utilized, as part of the code executable by one or moreelements of the detection system 300, to detect and further analyzedefects of portions of surgical instruments during a reprocessingprocedure. With reference to FIG. 7A, AI may be utilized to analyzeimaging received from an inspection camera translating within a lumen730A of a surgical instrument 700. For example, by comparing certainphysical characteristics of the lumen 730A a defect 700D₁ may bedetected. Through further analysis of the imaging associated with thedefect 700D₁, the detection system 300 may further determine that thedefect is a liquid or fluid. Turning to FIG. 7B, AI may be utilized todetect mechanical defects, such as defect 700D₂, which may be a scratchor other anomaly resulting from the passage of traumatic instrumentationthrough lumen 730B of surgical device 702. Alternatively, the defect700D₂ may be the result of a manufacturing anomaly. In either case, thedetection system 300 may message the end user to remove the medicalinstrument 702 from service and/or notify the end user that physiciantraining may be needed to help mitigate such medical device damage infuture procedures. As with FIG. 7B, FIG. 7C depicts a mechanical anomalyor defect 700D₃ in a lumen 730C of a medical device 704. Once thedetection system 300 has detected the defect 700D₃, the percentage ofwear associated with the lumen 730C can be determined and the remaininglifespan of the medical device 704 can then be calculated. FIG. 7Ddepicts another instance where a fluid or liquid, e.g., a defect 700D₄,is discovered in a lumen 730D of a surgical instrument 706. In thiscase, the detection system 300 may determine that the medical instrument706 may be further processed to remove the defect 700D₄, the medicalinstrument 706 then being put back into service. The detection system300 may be utilized to determine the nature of the defect and, further,the type of substance present, whether biological or non-biological, andthe final disposition of the associated medical device or instrument.All historical data associated with a specific medical instrument isstored, as described or contemplated herein.

A more specific location within a medical device of the various defectsdescribed above with reference to FIGS. 7A-7D may be determined throughthe use of various methodologies. One methodology, for example, may beoptical flow. The detection system 300 may know the initial position ofthe imaging device 310 relative to a device being inspected, one or moreof the medical devices 702, 704, 706, 708, for example. The detectionsystem 300 may then analyze the collected sequential images receivedfrom the imaging device to determine a more specific location of adefect located within the medical device. More specifically, throughoptical flow techniques the detection system 300 can analyze theprogression of images received by the imaging device 310 as the imagingdevice 310 translates through the medical device, and through opticalflow analysis of the objects observed in these images, includingdefects, a more accurate location of the defect 700D may be morereadily. Utilizing optical flow techniques, the detection system 300 maycalculate the motion between sequential images, taken at times t anddelta t, at every pixel position with respect to the spatial andtemporal coordinates of the imaging device 310.

Another methodology may include accelerometry. The detection system 300may analyze the images, as described immediately above, and calculate achange in position of the distal end of the imaging device 310 overtime, from which acceleration can be inferred. Instantaneous velocity,as well as distance, can be determined from this observed acceleration.Position data from the distal end of the imaging device 310 can becombined with data obtained through the optical flow methodologydescribed above to obtain better position data of a defect present inthe medical device. Such a process may be performed as part of the codeexecutable by one or more elements of the detection system 300.Alternatively, an accelerometer may be affixed to the distal end of theimaging device 310 for obtaining accelerometer data. The accelerometerdata may then be provided to the processor 330, or other processing unitof the detection system 300, to determine velocity and distance data,which then can be combined with the data obtained through the opticalflow methodology described above to obtain better position data of adefect present in the medical device.

Another methodology may be translation control of a motor utilized totranslate the imaging device 310 through a medical device where there isa known relationship between motor rotation and linear distancetraversed by the distal tip of the imaging device 310. For example, themotor may be a stepper motor with specific control over translationwhere upon a command the motor drive shaft rotates a known amount thatdirectly corresponds to a known linear distance the imaging device 310translates. Accordingly, once the imaging device is positioned at aknown initial position within the medical device a future translationalposition may be determined through the translation control of the motorand, ultimately, the location of the distal end of the imaging device310 and a defect it may be observing may also be known. Data obtainedthrough the use of this methodology may be used in combination with oneor more other methodologies to improve the determination of a defectlocation.

Once the defect detection and analysis are performed by the processor330 of the detection system 300, a user may log into the detectionsystem 300 via an input device, such as a tablet or computer system, andaccess the data associated with their particular medical facility. Aninspection technician, a risk manager, or quality assurance manager canaccess the detection system 300 and more specifically, the processor 330of the system, and request medical device data in accordance with theirtitle and search criteria. For example, a risk manager may request tosee medical device data associated with all scopes of a particular typefor a given time period, e.g., all colonoscopes for the current calendaryear. Alternatively, the user can request to see all scope types for alltime periods. Still, the user can request to see only those scopes thathave experienced mechanical defects or certain amounts of wearassociated with usage. The data may be accessed by various fields suchas by a medical facility department, a type of instrument, or an amountof mechanical data related to fatigue or wear. Accordingly, qualityassurance or quality management personnel of a medical facility canreview data in real-time and be audit-ready everyday such that when anaudit of the medical facility does occur, the associated medical devicedata is readily available. At the time of the audit limited access canbe provided to the auditor by the medical facility in order to directthe desired data to the auditor in support of the audit being performed,allowing the medical facility personnel to be more productive whileproviding a more efficient audit experience. In this way, managerialstaff of the medical facility can be prepared, with little or no notice,for upcoming audits, being able to provide auditors desired data insupport of the audit at the click of a button without having to gothrough a plethora or paper documents.

Turning back to FIG. 5 , the step 514 of acquiring imaging may includethe step of continuously acquiring imaging. Accordingly, once continuousimaging is being acquired, the detection scope may then be advanced inthe step 516 and defects may be identified in the step 518, and if theworking channel has not been reached the steps 516, 518 of advancing thedetection scope and identifying defects in the working channel may beperformed in a loop until the length of the working channel is reached,as indicated by dashed line 516L. In any case, since defectidentification is performed in real-time a technician or other workersupervising the reprocessing procedure may be immediately notified whena defect is identified, prompting the technician to review or note suchdefects. Alternatively, it should be readily apparent that while defectidentification is being performed simultaneously with advancement of thedetection scope in the depicted method 500, the step 518 of identifyingdefects may be performed at a later time. For example, the step ofdefect identification may be performed through image analysis after theend of the working channel has been reached by the detection scope.

Data associated with the reprocessing procedure may become part of oneor more of the data sources 330, 340, 350. Such data may include theone, some, or all of the images acquired, the rate at which thedetection scope is advanced through the working channel of thereprocessed medical device, and the type and nature of the defectsidentified. For example, mechanical wear may be obtained and analyzedsuch that an informed decision may be made regarding the lifespan of themedical device or whether the medical device should be removed fromservice. The acquired images may be obtained as individual images or acollection of images, as part of a video. Such images may be processedto increase the contrast of the walls of the working channel, allowingfor better defect detection.

It should be understood that features of any one of the above-describedembodiments described herein may be applied to any other of theabove-described embodiments, as appropriate. The devices contemplated ordescribed herein may be made from any suitable biocompatible material,including but not limited to metals, metal alloys (e.g., stainless steelor nitinol) and polymers (e.g., polycarbonate or Teflon™).

As is clear from the description above, the present technology offers acomputer-implemented process of detecting defects in medical devices andgenerating information for their subsequent use, i.e., a serviceprotocol or the like, with each protocol ideally tailored to theparticular medical device being inspected. Thus, the present technologycan reduce labor costs associated with the inspection of channels ofmedical scopes, reduce downtime, prevent the use of a device that mayharm a patient, etc.

Furthermore, although the present technology has been described above indetail with respect to various embodiments and examples thereof, thetechnology may be embodied in many different forms to implement thepresent invention. Thus, the present invention should not be construedas being limited to the embodiments and their examples described above.Rather, these embodiments and examples were described so that thisdisclosure is thorough, complete, and fully conveys the presentinvention to those skilled in the art. Thus, the true spirit and scopeof the present invention is not limited by the description above but bythe following claims.

What is claimed is:
 1. A method of servicing a medical device, comprising: imaging a working channel of the medical device with a detection scope to produce image data of the working channel; transmitting the image data to a processor; identifying defects of the medical device present along the working channel, from a select group of different types of defects, by analyzing the image data using the processor, and generating defect data representative of the types of any defects present along the working channel; obtaining procedural data from at least one memory, the procedural data including data selected from the group consisting of meta data of at least one patient who has undergone or is scheduled to undergo a medical procedure using the medical device, and device record data of a historical record of use of the medical device; and scheduling the medical device for servicing, removal from service, or for use in a next procedure without undergoing servicing based on the procedural data and the defect data.
 2. The method as claimed in claim 1, wherein the imaging of a working channel of the medical device comprises translating the detection scope along the working channel to produce the image data, and acquiring images of the working channel continuously as the device is translated along the working channel.
 3. The method as claimed in claim 2, further comprising: determining whether the detection scope has reached a location at an end of the working channel; advancing the detection scope along the working channel as long as the detection scope has not reached said location; repeating steps of imaging the working channel and generating defect data until the detection scope has reached said location; and updating the procedural data using the defect data after the detection scope has reached said location.
 4. The method of claim 1, wherein the select group of different types of defects includes at least one type each of a liquid contaminant and a mechanical defect.
 5. The method of claim 1, further comprising determining a relative location for each of the defects identified along the working channel.
 6. The method of claim 5, wherein the select group of different types of defects includes at least one type each of a liquid contaminant and a mechanical defect.
 7. The method of claim 5, wherein the determining of the relative location for each of the defects comprises performing an optical flow analysis.
 8. The method of claim 5, wherein the determining of the relative location for each of the defects comprises measuring an acceleration of a distal tip of the detection scope.
 9. The method of claim 5, wherein the determining of the relative location for each of the defects comprises measuring a ratio between a rotational movement of a motor and a linear movement of the detection scope.
 10. The method of claim 1, wherein the identifying of the defects comprises displaying images of each of the defects and overlaying a respective visual border around each of the defects in the images of the defects.
 11. The method of claim 10, further comprising presenting a textual identifier adjacent to the visual border.
 12. The method as claimed in claim 1, wherein the procedural data includes both the meta data and the device record data.
 13. The method as claimed in claim 12, wherein the procedural data also includes service data of medical procedures performed by the medical device at a medical facility or among a group of medical facilities, and further comprising correlating the service data with the device record data.
 14. The method as claimed in claim 1, wherein the defects are identified using artificial intelligence (AI), and the AI is used to determine the scheduling of the medical device for servicing, removal from service, or for use in a next procedure without undergoing servicing.
 15. A method of servicing a medical device, comprising: imaging a working channel of the medical device with a detection scope to produce image data of the working channel; analyzing the image data and generating defect data representative of the types of defects present along the working channel, from a select group of different types of defects, using artificial intelligence (AI); obtaining procedural data from at least one memory, the procedural data selected from the group consisting of meta data of at least one patient who has undergone or is scheduled to undergo a medical procedure using the medical device, and device record data of a historical record of use of the medical device; and using the AI to schedule the medical device for servicing, removal from service, or for use in a next procedure without undergoing servicing, based on the procedural data and the defect data.
 16. A method as claimed in claim 15, wherein the select group of different types of defects includes at least one type each of a liquid contaminant and a mechanical defect.
 17. The method as claimed in claim 15, wherein the procedural data includes both the meta data and the device record data.
 18. A medical device defect detection system, comprising: an imaging device comprising a detection scope insertable into a working channel of a medical device, the imaging device including an image sensor that captures images adjacent a distal end of the detection scope and generates image data representative of the images; a processor operatively connected to the imaging device to receive the image data, the processor configured to: analyze the image data, identify defects of the medical device present along the working channel from a select group of different types of defects by analyzing the image data using the processor, and generate defect data representative of the types of defects present along the working channel; and at least one memory storing procedural data including meta data of at least one patient who has undergone or is scheduled to undergo a medical procedure of a type performed by the medical device, and device record data indicative of a historical record of use of the medical device, the processor being operatively connected to the at least one memory and being configured to receive the procedural data from the at least one memory as well as update the procedural data using the defect data.
 19. The system as claimed in claim 18, wherein the processor is configured to schedule the medical device for servicing, removal from service, or for use in a next procedure without undergoing servicing based on an updated version of the procedural data stored in the at least one memory.
 20. The system as claimed in claim 18, wherein the detection scope also includes an elongate shaft adapted to be extended through a working channel of a medical device, a light source for illuminating the working channel, and a respective optical fiber extending through the elongate shaft and connected to each of at least one of the light source and the image sensor. 